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. 2020 Oct 16;2020(10):CD005262. doi: 10.1002/14651858.CD005262.pub4

Lee 2001a.

Study characteristics
Methods Study design: double‐blind, randomised
Country: Taiwan
Setting: single centre
Intention‐to‐treat: not mentioned
Participants Number of participants randomly assigned: 50
Number of participants analysed: 50
Exclusions postrandomisation: 0
Losses to follow‐up: 0
Age (mean): cilostazol: 66 (SD 9) years, pentoxifylline: 68 (SD 5) years, placebo: 69 (SD 6) years
Sex: male:female: cilostazol: 14/3, pentoxifylline: 14/3, placebo: 14/2
Inclusion criteria: aged > 40 years; stable PAD for ≥ 3 months; baseline maximum walking distance > 30 m and < 200 m; variance < 20% in maximum walking distance in the 2 screening tests
Exclusion criteria: Buerger's disease; category II or III chronic lower limb ischaemia; arterial surgery/angioplasty or sympathectomy within previous 3 months
Interventions Treatment: oral pentoxifylline, 400 mg twice bid
Control 1: oral cilostazol, 100 mg bid
Control 2: placebo
Duration: 8 weeks
Outcomes Primary: mean TWD
Secondary: ABI, side effects
Notes Treadmill protocol: 3.2 km/h at 12.5% gradient
Mean TWD expressed in metres only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomised code number according to which sponsor supplied the study drug."
Allocation concealment (selection bias) Low risk Sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Special drug packaging was used to maintain the blindness of the treatment code."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned.
Incomplete outcome data (attrition bias)
All outcomes Low risk No incomplete outcome data.
Selective reporting (reporting bias) Unclear risk Protocol not available; insufficient information available to permit judgement.
Other bias Low risk Study appeared free of other bias.